Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)

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This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.

Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.

Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.

Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.

Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.

Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

primary care clinic

Criteria

Inclusion Criteria for Cases:

Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair

Inclusion Criteria for Controls:

At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment

At least one dose of Xolair in the 18 months before the date of the case event (index date)

No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components